The U.S. Food and Drug Administration approved the expansion of Amgen’s Kyprolis (carfilzomib) U.S. prescribing information to include the product’s use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens – once weekly and twice weekly – for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.
The European Commission gave conditional approval for the use of remdesivir in severe COVID-19 patients following an accelerated review process, making the antiviral the region’s first authorized therapy to treat the virus.
The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.
The European Commission granted Marketing Authorization for Shire’s ADYNOVI [Antihemophilic Factor (Recombinant), PEGylated], for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
Vertex Pharmaceuticals Incorporated announced that the European Commission granted extension of the Marketing Authorization for Orkambi (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people with two copies of the F508del mutation, to include children ages 6 through 11.
Samsung Bioepis Co. Ltd. announced the European Commission’s marketing authorization of Ontruzant – a biosimilar referencing Herceptin (trastuzumab) – for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Ipsen today announced that the European Commission approved Xermelo (telotristat ethyl) 250 mg three times a day for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
